NCT04221152

A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )

A Multicenter, Open-label, Single-arm, Extension Study With Regard to the Safety and Efficacy of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance (EMPIRE-02)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Kobe University · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy of empagliflozin in patients with refractory diabetes mellitus with insulin resistance.

Detailed description

To determine the safety and efficacy of oral administration of empagliflozin 10 mg or 25 mg once daily for 28 weeks (52 weeks of the EMPIRE-01 study) in subjects who participated in the EMPIRE-01 study, which was conducted on refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) in a multicenter, open-label, single-arm, extension study.

Conditions

• Insulin Resistance - Type A
• Insulin Resistance - Type B
• Lipoatrophic Diabetes Mellitus
• Insulin Resistance Syndrome

Interventions

Type	Name	Description
DRUG	Empagliflozin Tablets	The administration is oral administration with water before or after breakfast.

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-02-01
• Completion: 2022-05-31
• First posted: 2020-01-09
• Last updated: 2021-06-03

Locations

5 sites across 1 country: Japan